New Medicines: Issues of Approval, Access, and Product Safety

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Medicines unquestionably save lives and improve health and the quality of life. On rare occasions, they also harm and kill those who take them. Lab scientists around the world experiment with new medications to combat illnesses and to relieve pain and stress. Sometimes, even when they are used properly, the medicines' effects are not entirely good. Drugs approved by the U.S. Food and Drug Administration regularly are found to produce unforeseen and dangerous, sometimes deadly, side effects--after years of prescribed use, in some cases. That is why extensive testing is required before a new medication becomes available to the general public. Yet many consumers do not understand why the FDA seems to drag its feet in approving new medications that offer terminally ill patients hope for a cure. In this engrossing book, readers learn about the disagreement over the process of developing and distributing medicines. They understand the distrust toward drug makers, government regulators, and distributors, and examine the questions of timing and costs. But what about those cases in which the side effects of a dangerous drug have not come to light until many years after the drug was approved for marketing? How many years should scientists, drug companies, FDA officials, and doctors wait before the testing ends and they can introduce a new medicine, concluding that it is safe to use?